UNDECYLENIC ACID- anti-fungal pen liquid
Premier Brands of America Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Premier Brands Anti-Fungal Pen

Active ingredient

Undecylenic acid 25%w/w

Purpose

Antifungal

Uses

For cure of most tinea pedis (athlete's foot) and tinea corporis (ringworm).

For relief of:

itching
burning
redness
irritation
scaling
soreness
discomfort which may accompany these conditions

Warnings

For external use only

If pregnant or breastfeeding

consult a healthcare professional before use.

Do not use

on children 2 years of age unless directed by a doctor.

When using this product

avoid contact with eyes

Use only as directed

by a doctor on persons with highly sensitive skin.

Stop use and consult a doctor if

there is no improvement within 4 weeks
irritation occurs

Keep out of children.

If accidental ingestion occurs, get medical help or contact a Poison Control Center right away.

Directions

Read all warnings and directions. Use only as directed.

clean the affected area and dry thoroughly
twist pen base with 3 clicks to saturate brush
apply a thin layer of the product over the affecter area twice daily (morning and night) or as directed by a doctor
brush applicator allows for easy application under nails and surrounding cuticle area
supervise children in the use of this product
for athlete's foot: pay special attention to spaces between toes
wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks. If conditions persists longer, consult a doctor
this product is not effective on the scalp or nails

Other information

store at room temperature 15°-30°C (59° - 86°F)
protect from freezing. If freezing occurs warm to room temperature
keep tightly closed when not in use

Inactive ingredient

isopropyl palmitate

Questions?

Call 1-866-964-0939

Principal Display Panel

Premier

Maximum Strength

Anti-fungal Pen

25% Undecylenic Acid

Eliminates fungus on fingers, toes and around nails

Pre-filled applicator pen brush
Convenient & easy to apply
Dries quickly
Non-oily clear formula

Net Contents: 0.057 FL OZ(1.7mL)

PB Anti-Fungal Nail Solution Pen Box-.jpg

UNDECYLENIC ACID
anti-fungal pen liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56104-116
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	40 mg in 1.7 mL

Ingredient Name	Strength
Inactive Ingredients
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)	120 mg in 1.7 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56104-116-17	1.7 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product	07/01/2013	12/08/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	07/01/2013	12/08/2020

Labeler - Premier Brands of America Inc. (117557458)

Revised: 1/2023

Document Id: f32cabb5-0e49-1e0e-e053-2995a90a6c70

Set id: 4424ee27-f9bf-4bb2-8294-b12c73f43e81

Version: 6

Effective Time: 20230126

Premier Brands of America Inc.